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Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00875147
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : October 25, 2016
Information provided by (Responsible Party):
Ksenija Slankamenac, University of Zurich

Brief Summary:
Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative outcome after resection of colorectal liver metastases.

Condition or disease Intervention/treatment
Colorectal Liver Metastases Drug: bevacizumab

Detailed Description:

Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF) increasingly added to other drugs in the treatment of colorectal cancer. Bev is typically used in combination with other chemotherapeutic agents such as oxaliplatin, irinotecan, leucovorin and 5-fluorouracil (5-FU) for treatment of patients with CRLM. The objective of this study was to assess the impact of neoadjuvant bevacizumab on clinical outcome after hepatectomy of colorectal liver metastases (CRLM).

Patients, who underwent liver resection due to colorectal liver metastases after neoadjuvant chemotherapy, operated between 2005 and 2007 will be evaluated retrospectively. The patients will be distributed in two groups, either with or without bevacicumab. Outcome parameters are mortality, complications, hospital stay and ICU stay. To increase the power of the study the total number of patients will be increased by adding patients from other centers. Results will be adjusted for the propensity of developing complications.

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Study Type : Observational
Actual Enrollment : 163 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases A Case Matched Control Study
Study Start Date : April 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Group/Cohort Intervention/treatment
with bevacizumab
Neoadjuvant chemotherapy with bevacizumab
Drug: bevacizumab
Neoadjuvant chemotherapy with bevacizumab

without Bevacizumab
Neoadjuvant chemotherapy without Bevacizumab

Primary Outcome Measures :
  1. Overall complications [ Time Frame: postoperative ]

Secondary Outcome Measures :
  1. specific complications such as liver insufficiency, length of hospital stay [ Time Frame: postoperative ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients, who underwent liver resection due to CRLM between 2005 and 2007, were retrospectively assessed for eligibility. Patients with chemotherapy containing Bev prior to surgery are identified consequtively. This group of patient with preoperative Bev is matched to patients without Bev. Consecutive patients with neoadjuvant application of Bevacizumab will be matched to patients without Bevacizumab. Results are statistically adjusted according to potential confounders.

Inclusion Criteria:

  • Patients with neoadjuvant chemotherapy prior to liver resection

Exclusion Criteria:

  • Patients without neoadjuvant chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00875147

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Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital
Strasbourg, France
Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital
Girona, Spain
University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Stefan Breitenstein, MD Departement of Visceral and Transplantation Surgery of University hospital of Zurich

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Responsible Party: Ksenija Slankamenac, MD, University of Zurich Identifier: NCT00875147    
Other Study ID Numbers: StV 12-2009
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: January 2010
Keywords provided by Ksenija Slankamenac, University of Zurich:
neoadjuvant chemotherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors